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1. Intended Use
The NADAL® Strep A test cassette by nal von minden is a
lateral flow, one-step immunoassay for the rapid, qualitative
detection of Group A Streptococcal antigen directly from
throat swabs.
2. Introduction and/or Clinical Significances
Beta-hemolytic Group A Streptococcus is a major cause of
upper respiratory infections such as tonsillitis, pharyngitis, and
scarlet fever. Early diagnosis and treatment of Group A
Streptococcal pharyngitis has been shown to reduce the
severity of symptoms and further complications, such as
rheumatic fever and glomerulonephritis.
Conventional methods used for the detection of the disease
depend on the isolation and subsequent identification of the
organism. These methods often require 24-48 hours to
complete. Recent development of immunological techniques
which can detect Group A Streptococcal antigen directly from
throat swabs, allow physicians to diagnose and administer
therapy immediately.
3. Principle of the Test
The NADAL® Strep A Test utilises a two site sandwich immu-
noassay technology for the detection of Group A Streptococcal
antigen. The test device consists of a plastic housing contain-
ing a nitro cellulose membrane strip which has been pre-
coated with rabbit anti-Strep A antibody on the test band
region and goat anti-rabbit antibody on the control band
region. A coloured rabbit anti-Strep A polyclonal antibody-
colloid gold conjugate pad is placed at the end of the mem-
brane. During testing, the Strep A antigen is extracted from
the throat swab using Extraction Reagents 1 and 2. The
extracted solution is then added to the sample well. The Strep
A antigen reacts with the coloured antibody-colloidal gold
conjugate to form Strep A antigen-antibody complexes. The
mixture then moves chromatographically across the mem-
brane to the immobilised rabbit anti-Strep A antibody at the
test band region. If Strep A antigen is present in the specimen,
a pink coloured sandwich of solid phase/Strep A antigen/gold
conjugate is formed on the test band region. Absence of the
pink coloured band at the test band region indicates a nega-
tive result. Regardless of the presence of Strep A antigen, as
the extracted mixture continues to move laterally across the
membrane to the immobilised goat anti-rabbit antibody test
band region, a pink coloured band at the control region should
always appear. The presence of this coloured band serves as:
1) verification that sufficient volume has been added; 2)
verification that proper flow is obtained and; 3) reagent
control.
4. Reagents and Materials Supplied
20 NADAL® Strep A test cassettes incl. disposable droppers:
plastic housing, containing rabbit anti-Strep A antibody
coated membrane and colloid gold conjugate
1 bottle Extraction Reagent # 1: 1.0 M Sodium Nitrite (7 ml).
T: Toxic
R25: Toxic if swallowed
1 bottle Extraction Reagent # 2: 0.4 M Acetic Acid (7 ml).
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® Strep A Test (test cassette)
(Ref. 222001A)
1 bottle Positive control: From heat inactivated Group A
Streptococcus in solution (1×10
sodium azide as preservative.
20 Extraction Tubes incl. Dropper-Caps
1 Tube rack
Provided additional material according to 39/42/EEC:
20 sterile throat swabs CE 0086
Puritan Medical Products Company LLC
31 School Street
Guilford, Maine 04443-0149 USA (authorized EU repre-
sentative EMERGO EUROPE, The Hague, The Netherlands)
1 Instruction manual
5. Additional Required Materials
Timer
6. Storage & Stability
All reagents included in the NADAL® Strep A test cassette can
be stored at room temperature or refrigerated (2-30°C).
7. Warnings and Precautions
For in vitro diagnostic use only.
For professional use only
For single use only
Do not mix reagents from different lots.
Do not mix reagent bottle caps.
Do not use after stated expiration date.
Do not eat, drink or smoke in the area where the specimens
or kits are handled.
Do not use test if pouch is damaged.
Do not use swab if its pouch is damaged.
Use only Dacron or Rayon tipped sterile swabs with plastic
shafts such as those provided. Do not use calcium alginate,
cotton tipped, or wooden shafted swabs.
Do not use more than the required amount of liquid
Extraction Reagent 1 is toxic at swallowing
Extraction Reagents 1&2 are slightly caustic. Avoid contact
with eyes or mucous membranes. In the event of accidental
contact, wash thoroughly with water.
Positive control contains sodium azide which may react with
lead or copper plumbing to form potentially explosive metal
azides. When disposing of these solutions always flush with
copious amounts of water to prevent azide build-up.
Bring all reagents to room temperature (15-30°C) before
use
Do not spill the samples into the reaction zone
Do not touch the reaction zone of the device to avoid
contamination
Avoid cross-contamination of samples by using a new
specimen collection container and specimen pipette for
each sample.
Standard guidelines for handling infectious agents and
chemical reagents should be observed throughout all pro-
cedures.
All contaminated waste such as swabs, Strep A Test devices
and extracts should be properly disposed.
Wear protective clothing such as laboratory coats, disposa-
ble gloves and eye protection when specimens are being
tested.
Evaluate the test result after 5 minutes.
8
organism/ml) with 0.1%
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